08:13 AM EDT, 11/01/2024 (MT Newswires) -- Biogen (BIIB) and Eisai said late Thursday that Eisai finalized a biologics license application rolling submission to the FDA for a subcutaneous autoinjector of LEQEMBI, or lecanemab-irmb, for weekly dosing in early-stage Alzheimer's disease.

The device, which is designed for home or clinic use, allows a 15-second injection and supports sustained drug levels to clear toxic protofibrils linked to Alzheimer's disease progression.

Biogen is co-commercializing and co-promoting the product, while Eisai serves as the lead for lecanemab's development and regulatory submissions, the companies said.

Eisai said the FDA set the Prescription Drug User Fee Act, or PDUFA action date for January 25, 2025.

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